Industry/Licensing

Licensing

New vaccine candidates are reviewed by the FDA’s Center for
Biologics Evaluation and Research (CBER). CBER reviews
applications for licensure of vaccines, evaluates the manufacturers
that produce these products, and enforces compliance with these
standards. Additional guidance and information about
licensing can be found on the CBER website.

Childhood vaccination in the United States, including vaccine
purchase, distribution, and administration, occurs via a
collaboration of public and private efforts. Approximately 56
percent of all childhood vaccine is purchased with public dollars,
including federal, state and local funds; the remaining vaccine is
purchased privately. The majority of publicly-purchased vaccine is
distributed to and administered by health care professionals in the
private sector. Privately purchased vaccine is administered almost
exclusively within the private sector.

The Vaccines for Children,
or VFC, program buys vaccines for children in certain
groups who can't afford to buy vaccines. Doctors can get
these vaccines for their patients who qualify by joining the VFC
program in their state.